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QC testing of small molecules (DS/DP)

In search of excellence: QC testing for small molecules

Our three GMP facilities have established analytical platforms that enable us to scale analytical work according to your requirements within short lead times. In addition, our centers of excellence can propose specific analytical techniques customised to your needs – all under one roof. We help ensure the timely placing of your GMP batches on the market through our analysis and release of active ingredients, packaging, and finished products in accordance with the provisions of the EU GMP Guideline, and by creating certificates of analysis (CoA) according to their specifications. Optionally, the partial certification of batches can be performed by one of our EU-QP.

Hand with purple gloves in front of the plate where HPLC vials are displayed

Compendial tests 

We offer comprehensive compendial quality control (QC) testing services for both active pharmaceutical ingredients (APIs) and drug products. These services adhere to established pharmacopeial standards, including tests for assay, impurities, identification, dissolution, sterility and more. 

 

Non-compendial tests  – assays, impurities, and more

In contrast to compendial methods, non-compendial analytical methods are not considered to be standardised methods as per US Pharmacopeia. For this reason, they require elaborate method development according to the product’s quality attributes and subsequent validation within the testing site.

At Nuvisan, we offer customised development and validation of methods for a vast variety of non-compendial quality control (QC) testing services for both active pharmaceutical ingredients (APIs/HPAPIs) as well as formulated drug products of small molecules.

Dissolution

Dissolution testing is particularly important for oral dosage forms, as it directly impacts how drugs are absorbed by the body. By helping ensure that a product consistently dissolves in the required time and to the expected extent, we provide critical support for safe, effective and compliant drug products Our comprehensive dissolution testing is conducted under conditions that simulate real-life biological environments, typically using different dissolution media to mimic various pH levels and physiological conditions encountered in the human body.

Our facilities are equipped with advanced dissolution apparatus, including USP-compliant models, allowing us to perform a wide range of tests, such as:

  • Routine dissolution testing: Standard tests for both solid and semi-solid dosage forms, like tablets, capsules and controlled-release formulations
  • Stability-indicating testing: Helping ensure that a product's dissolution profile remains consistent over time, even when exposed to varying environmental conditions
  • Method development and validation: Developing and validating dissolution testing methods for new drug formulations, helping ensure they meet the appropriate regulatory standards

Our lab is equipped with reciprocating cylinder and flow-through cell dissolution apparatus to cover special requests involving pH profiling or slow soluble drugs.

These services can help our clients meet regulatory requirements and ensure that their products maintain quality and effectiveness throughout a product's shelf life. 

Qualification of standard and reference materials 

To help ensure high-quality analytical testing, an independent supply of standard and reference materials is a key factor. The qualification and re-qualification of such materials is one of the benefits we offer in our labs. The materials are qualified in compliance with the actual effective regulations.

 
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